Events

Recall of Alaris

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0492-2011
  • Event Initiated Date
    2010-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93511
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, Infusion - Product Code FRN
  • Reason
    Than recall was initiated because carefusion has identified identified a potential risk associated with the alaris pc unit formerly known as medley pc unit (pc unit) model 8000 only when used with alaris pump module (pump module) or alaris syringe module' (syringe module), this recall notification details the potential risk and recommended steps for users to take if they encounter a specific pc.
  • Action
    CareFusion will send by registered return receipt mail the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, selfaddressed mail, fax or email. The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users. The customers were also told that CareFusion is working to release a software update to address this display error and will contact your facility as soon as the software update is available. CareFusion does not require that you return your devices. Clinicians should weigh the risk/benefits to the patients before continuing the use of the device. Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.

Device

Alaris
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States, Canada, Mexico, and the European Union
  • Product Description
    Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module
  • Manufacturer
    CareFusion Corporation

Manufacturer

CareFusion Corporation
  • Manufacturer Address
    CareFusion Corporation, 10020 Pacific Mesa Blvd, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA